PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 115

TABLE 6.6 ( Continued )

Controls

Failure Cause in place

# Mode of Failure Effect Controls Comments Yes/No

7. Shared

equip-
ment

Failure to clean
properly or use
of equipment
for R&D and
QC glassware/
biological
glassware
together with
GMP items

Cross-
contamination/
contamination

• Provision of separate equipment
such that equipment
(dishwasher) and all
manufacturing items are only
for GMP use-there is no longer
any need for R&D or
biology/QC to use them as they
have their own equipment
• At present only one API used in
GMP facility so that cleaning is
a minor concern
• Line clearance procedure before
manufacture for human use

Risk mitigated YES

8. Equipment
dirty

Poor design Cross-

contamination/
contamination

Risk mitigated bearing in
mind that no potent
compounds are used at
company at present

YES

• Item of primary concern is the
lyophilizer which is not
inherently sanitary design. Risk
mitigated by use of sealed,
single-use Lyoguard trays for
product drying. Together with a
visually clean criteria after
cleaning the inside of the
chamber